Animas® IR 1200, Animas® 2020, One Touch® Ping® Glucose management system, Animas® Vibe™ 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2012/059

CON180652

2012-08-22

2012-08-22

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON180652?tabName=allTabs

Risk of compromised insulin therapy due to failure of the buttons caused by keypad wear. the manufacturer has noted an increase in customer complaints regarding the durability of the insulin pump keypad. deterioration has led to the coating tearing and the edge of the keypad peeling away from the pump. there are also reports of the keys becoming unresponsive or sticking. animas has consequently redesigned the keypad to improve durability. the manufacturer has found that the average time to failure is 18 months. animas distributed a patient notification letter on the 16 july 2012 (see appendix). there is updated information on the animas website (external link).

Check the list of serial numbers affected in the Animas UK document. Ensure that patients using the pump are aware of: the potential for buttons to fail. the need to examine the keypad regularly for signs of wear, such as peeling or tearing of the keypad edge from the pump. the need to have a back-up insulin delivery method available at all times. Patients and healthcare providers should refer to the updated Animas patient information in the appendix. Patients who identify problems with, or have concerns about, their pump’s keypad should contact their health care provider and Animas customer technical support. Report any problems with the pump to the MHRA. Diabetes departments. Pharmacists. Those involved in procurement, supply and use of this device.